NCT01355484

Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)

Phase III, Randomized, Double-Blind, Placebo Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer on First Line Platinum Plus a Taxane Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: GTx · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the investigational drug GTx-024 can help subjects with non-small cell lung cancer increase physical function and maintain or gain muscle, also called "lean body mass".

Detailed description

This is a randomized, double-blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer (NSCLC). Subjects will be evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The primary efficacy analysis will be based on total lean body mass and physical function.

Conditions

• Muscle Wasting
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GTx-024	subjects will be randomized to receive GTx-024 for the full duration of the trial.
DRUG	placebo	subject will receive placebo for the duration of the trial

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-05-01
• Completion: 2014-06-01
• First posted: 2011-05-18
• Last updated: 2016-03-03
• Results posted: 2016-03-03

Locations

27 sites across 1 country: United States